FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
K Number: K172659
·
Decision Sep 28, 2017
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
142
Applicant Total
8
Review Days
23
Basic Information
- Device Name
- MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
- K Number
- K172659
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- M/s. Meril Endo Surgery Private Limited
- Date Received
- September 5, 2017
- Decision Date
- September 28, 2017
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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Other Clearances by M/s. Meril Endo Surgery Private Limited
| K Number | Device Name | ||
|---|---|---|---|
| K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | Apr 25, 2024 | Substantially Equivalent |
| K200452 | Meril-Bonewax | Mar 27, 2023 | Substantially Equivalent |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | Feb 5, 2021 | Substantially Equivalent |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | Nov 23, 2020 | Substantially Equivalent |
| K172146 | MERISTEEL | Feb 1, 2018 | Substantially Equivalent |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | Oct 20, 2017 | Substantially Equivalent |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | Oct 14, 2015 | Substantially Equivalent |