M/s. Meril Endo Surgery Private Limited.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “M/s. Meril Endo Surgery Private Limited.” (first 2015, latest 2025), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 222 days. Since 2017 the median was 254 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 209 |
| 2016 | 1 | 88 |
| 2017 | 2 | 59 |
| 2018 | 1 | 199 |
| 2019 | 0 | — |
| 2020 | 1 | 306 |
| 2021 | 1 | 364 |
| 2022 | 0 | — |
| 2023 | 1 | 1127 |
| 2024 | 3 | 272 |
| 2025 | 1 | 33 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name M/s. Meril Endo Surgery Private Limited. took a median 254 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 2 |
| GAP | Suture, Nonabsorbable, Silk | 2 | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 2 |
| FZP | Clip, Implantable | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 1 |
| MTJ | Wax, Bone | 1 | 1 |
Review panels
Most recent M/s. Meril Endo Surgery Private Limited. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | NEW | 2025-09-23 | 33 |
| K233386 | Monik - Disposable Endoscopic Trocar | GCJ | 2024-05-24 | 235 |
| 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 | NEW | 2024-04-25 | 272 |
| K230981 | Meriglu Topical Skin Adhesive | MPN | 2024-03-16 | 346 |
| K200452 | Meril-Bonewax | MTJ | 2023-03-27 | 1127 |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | GDW | 2021-02-05 | 364 |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | FZP | 2020-11-23 | 306 |
| K172146 | MERISTEEL | GAQ | 2018-02-01 | 199 |
| 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 | 2017-10-20 | 95 |
| 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 | 2017-09-28 | 23 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named M/s. Meril Endo Surgery Private Limited..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under M/s. Meril Endo Surgery Private Limited.?
FDA lists 12 510(k) clearances under the applicant name “M/s. Meril Endo Surgery Private Limited.” (first 2015, latest 2025), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by M/s. Meril Endo Surgery Private Limited.?
The median time from FDA receipt to decision across 510(k)s cleared under the name M/s. Meril Endo Surgery Private Limited. is 222 days. Since 2017: 254 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under M/s. Meril Endo Surgery Private Limited.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 2); GAP (Suture, Nonabsorbable, Silk, 2); NEW (Suture, Surgical, Absorbable, Polydioxanone, 2).
Next steps
- See all 12 M/s. Meril Endo Surgery Private Limited. clearances with predicates and recalls
- Run predicate analysis for product code GAM, M/s. Meril Endo Surgery Private Limited.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.