Data / Medical devices / India / Meril Endo Surgery Pvt. Ltd.
Meril Endo Surgery Pvt. Ltd.: FDA-registered device maker in Vapi Gujarat, India, 9 510(k) clearances
Meril Endo Surgery Pvt. Ltd. is registered with the FDA (registration 3007205024) in Vapi Gujarat, India. It lists 18 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007205024
- Address
- Meril Campus, B. No. 8 - F3 and B. No. 6 - F0, F1, F4 Muktanand Marg, Vapi Gujarat, India, 396191
- Owner or operator
- Meril Endo Surgery Pvt. Ltd. (10051260)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 3, 2017
- Registered through
- 2026
- Brand names listed
- ANARA, ARYA, ARYA FA, CASERTA, COMETA, Chromic Gut, DECORI, ELARA Sterile Disposable Skin Stapler and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2025 | K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | NEW | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| March 16, 2024 | K230981 | Meriglu Topical Skin Adhesive | MPN | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| March 27, 2023 | K200452 | Meril-Bonewax | MTJ | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| February 5, 2021 | K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | GDW | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| November 23, 2020 | K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | FZP | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| February 1, 2018 | K172146 | MERISTEEL | GAQ | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| October 20, 2017 | 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 | GAP | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| September 28, 2017 | K172659 | 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 | GAM | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
| May 31, 2016 | 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 | GAP | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
- All makers of Suture, Nonabsorbable, Silk
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- All makers of Suture, Nonabsorbable
Updated September 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.