Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M/s. Meril Endo Surgery Private Limited. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
235 daysmedian FDA review time
364 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 | 33 | 0 |
| K233386 | Monik™ - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | 2024-05-24 | 235 | 0 |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanon | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 | 272 | 0 |
| K230981 | Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. | 2024-03-16 | 346 | 0 |
| K200452 | Meril-Bonewax | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 | 1127 | 0 |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Miru | M/s. Meril Endo Surgery Private Limited. | 2021-02-05 | 364 | 0 |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | M/s. Meril Endo Surgery Private Limited. | 2020-11-23 | 306 | 0 |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 | 199 | 0 |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILA | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 | 95 | 0 |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Sut | M/s. Meril Endo Surgery Private Limited. | 2017-09-28 | 23 | 0 |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILA | M/s. Meril Endo Surgery Private Limited. | 2016-05-31 | 88 | 0 |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | M/s. Meril Endo Surgery Private Limited. | 2015-10-14 | 209 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda