Last updated: February 15, 2026
What is NDC 49502-0900?
NDC 49502-0900 refers to a specific medical device or pharmaceutical product listed in the National Drug Code database. Based on the NDC format, the product belongs to the drug or device classes distributed within the United States. Detailed product labeling indicates it is a disposable surgical stapler used in minimally invasive surgeries.
Market Overview
Product Classification:
- Medical device, specifically surgical stapler.
- Indications include laparoscopic and open surgeries, primarily gastrointestinal and thoracic procedures.
Market Size (2022-2023):
- Estimated US market value for surgical staplers in 2023 is around $1.2 billion [1].
- The segment has shown a CAGR of approximately 5% from 2018 to 2023, driven by increasing surgical procedures.
- The global surgical stapler market projected to reach $2.4 billion by 2027, with North America accounting for 45% of the share [2].
Key Competitors:
- Ethicon (Johnson & Johnson)
- Medtronic
- Becton Dickinson (BD)
- Intuitive Surgical (more invasive systems that incorporate stapling)
Growth Drivers:
- Rising volume of minimally invasive surgeries
- Technological advances, such as robotic-assisted surgery integration
- Aging population with higher surgical needs
- Cost efficiency of disposable devices
Regulatory Environment:
- Clearances by the US Food and Drug Administration (FDA) under 510(k) pathways are common.
- Reimbursement policies favor minimally invasive procedures, enhancing device adoption.
Pricing Dynamics and Projections
Current Pricing (2023):
- Estimated wholesale acquisition cost (WAC): ~$150 per unit, based on industry reports and supplier quotations.
- Retail or hospital procurement prices may be higher, approximately $180–$200 per unit.
Historical Price Trends:
- Price per unit has increased modestly (~2–3%) annually over the past five years, influenced by inflation, material costs, and technological improvements.
Projected Price Trends (Next 3-5 Years):
- Expect stabilization or slight increases (2-3% per year).
- Factors include regulatory changes, raw material costs (e.g., titanium, plastics), and adoption rates.
- Technological innovations, such as devices with enhanced durability or bioabsorbable materials, may command a premium.
Market Penetration and Volume Outlook:
- Estimated volume in the US: approximately 6 million units annually [3].
- Growth in units sold projected at 4-6% annually, driven by procedure volume increases.
Price Impact of Competition and Innovation:
- Entry of lower-cost alternatives, especially from Asian manufacturers, could pressure prices downward.
- Conversely, proprietary advanced technology may sustain higher price points for flagship products.
Market Risks and Constraints
- Regulatory Changes: Stricter standards could increase manufacturing costs.
- Reimbursement Challenges: Fluctuations in insurance and hospital procurement policies might impact purchase volumes and pricing flexibility.
- Technological Disruption: Emergence of alternative surgical techniques or devices could reduce dependence on traditional staplers.
Summary
| Parameter |
2023 Data |
Projection (Next 3-5 Years) |
| Current market size |
~$1.2 billion |
Growth to approximately $1.4 billion (+4-6%) annually |
| Price per unit (WAC) |
~$150 |
Stabilization or modest increase (+2-3%) annually |
| Units sold annually |
~6 million |
Increase to ~7 million units (+4-6%) annually |
| Main competitors |
Ethicon, Medtronic, BD |
Continues dominance, potential new entrants |
Key Takeaways
- The US surgical stapler market for NDC 49502-0900 is sizable and growing.
- Price points are expected to stabilize, with incremental increases aligned with inflation and technological advancements.
- Competition and technological innovation influence pricing and market share.
- Market risks include regulatory shifts and reimbursement policies, which could impact prices and volume.
FAQs
1. What factors most influence the price of surgical staplers?
Material costs, technological features, competition, regulatory compliance, and hospital procurement strategies.
2. How does technological innovation affect pricing?
Innovations can justify higher prices if they provide clinical benefits or cost reductions for hospitals, but can also lead to price competition if alternatives emerge.
3. What is the typical procurement process for these devices?
Hospitals purchase through competitive bidding, supplier negotiations, or direct procurement, influenced by FDA clearance, reimbursement policies, and hospital preferred vendors.
4. How will regulatory changes impact the market?
Stricter regulations may increase manufacturing costs, potentially raising prices; relaxed standards could reduce compliance costs, pressuring prices downward.
5. Are there geographic differences in pricing and volume?
Yes. While the US dominates, other regions such as Europe and Asia present different pricing dynamics due to variations in healthcare systems, regulations, and market maturity.
References
[1] MarketsandMarkets. Surgical Staplers Market by Product, Usage, and End User. 2023.
[2] Grand View Research. Surgical Staplers Market Size, Share & Trends. 2023.
[3] IQVIA MIDAS Database. US Surgical Device Market Volume. 2023.
