FDA applicant
M/s. Meril Endo Surgery Private Limited.
FDA records 12 decisions for M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN) from 2015 to 2025: 12 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAP (Suture, Nonabsorbable, Silk). Since 2016 its 510(k)s took a median of 272 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided M/s. Meril Endo Surgery Private Limited.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like M/s. Meril Endo Surgery Private Limited.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report