FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
K Number: K960653
·
Decision Mar 28, 1996
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
6
Applicant Total
204
Review Days
42
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Basic Information
- Device Name
- MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
- K Number
- K960653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, Inc.
- Date Received
- February 15, 1996
- Decision Date
- March 28, 1996
- Product Code
- GAN
- 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 |
|---|---|---|---|
| GAN | Suture, Absorbable, Synthetic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAN), ordered by most recent decision date.
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POLYSORB SYNTHETIC ABSORBABLE SUTURE
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Other Clearances by ETHICON, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | May 18, 2026 | Substantially Equivalent |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | Mar 27, 2026 | Substantially Equivalent |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | Feb 6, 2026 | Substantially Equivalent |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Dec 22, 2025 | Substantially Equivalent |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | Nov 12, 2025 | Substantially Equivalent |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Nov 15, 2022 | Substantially Equivalent |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | Feb 22, 2022 | Substantially Equivalent |
| K213512 | DERMABOND PRINEO Skin Closure System | Dec 7, 2021 | Substantially Equivalent |
| K201996 | Monocryl Plus Antibacterial Suture | Dec 21, 2020 | Substantially Equivalent |
| K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide | Sep 17, 2020 | Substantially Equivalent |