FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
K Number: K043388
·
Decision Aug 5, 2005
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
5
Review Days
239
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
- K Number
- K043388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pegasus Biologics, Inc.
- Date Received
- December 9, 2004
- Decision Date
- August 5, 2005
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTM), ordered by most recent decision date.
Endoform Reconstructive Template - PLGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long-Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CanGaroo RM Antibacterial Envelope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Peri-Guard and Supple Peri-Guard
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery