# M/s. Meril Endo Surgery Private Limited.

- Location (FDA's records): Chala, Vapi, IN
- FDA decisions: 12 (2015–2025): 12 510(k) clearances
- Product codes: GAM (2), GAP (2), NEW (2), GCJ (1), MPN (1), MTJ (1), GAQ (1), FZP (1), GDW (1)
- 510(k) review time since 2016: median 272 days, against 146 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 5 (https://510kreport.com/company/ethicon)
- Sutures India Private Limited: 3 (https://510kreport.com/company/sutures-india-private)
- Cp Medical: 2 (https://510kreport.com/company/cp-medical)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd: 1 (https://510kreport.com/company/changzhou-xin-neng-yuan-medical-stapler)
- Surgical Specialties Corp: 1 (https://510kreport.com/company/surgical-specialties)
- Weck Closure Systems: 1 (https://510kreport.com/company/weck-closure-systems)
- Golden Stapler Surgical Co., Ltd.: 1 (https://510kreport.com/company/golden-stapler-surgical)

## Firms that cite its devices most
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)
- Shandong Haidike Medical Products Co., Ltd.: 1 (https://510kreport.com/company/shandong-haidike-medical-products)

## Its most-cited devices
- K150717: Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron (2015), cited by 1
- K160623: 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 (2016), cited by 1
- 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 (2017), cited by 1
- K200166: Mirus Ligating Clip, Mirus Ligating Clip Applier (2020), cited by 1
- 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 (2024), cited by 1

## Recent decisions
- K252644: PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (Sep 23, 2025)
- K233386: Monik™ - Disposable Endoscopic Trocar (May 24, 2024)
- 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)
- K230981: Meriglu Topical Skin Adhesive (Mar 16, 2024)
- K200452: Meril-Bonewax (Mar 27, 2023)
- K200320: Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload (Feb 5, 2021)
- K200166: Mirus Ligating Clip, Mirus Ligating Clip Applier (Nov 23, 2020)
- K172146: Meristeel (Feb 1, 2018)

Source page: https://510kreport.com/company/m-s-meril-endo-surgery-private