Company · IN
M/s. Meril Endo Surgery Private Limited.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 |
| GAP | Suture, Nonabsorbable, Silk | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 |
| FZP | Clip, Implantable | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GDW | Staple, Implantable | 1 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 |
| MTJ | Wax, Bone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2025 | K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbabl M/s. Meril Endo Surgery Private Limited., IN | NEW |
| May 24, 2024 | K233386 | Monik - Disposable Endoscopic Trocar M/s. Meril Endo Surgery Private Limited., IN | GCJ |
| Apr 25, 2024 | K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Abs M/s. Meril Endo Surgery Private Limited., IN | NEW |
| Mar 16, 2024 | K230981 | Meriglu Topical Skin Adhesive M/s. Meril Endo Surgery Private Limited., IN | MPN |
| Mar 27, 2023 | K200452 | Meril-Bonewax M/s. Meril Endo Surgery Private Limited., IN | MTJ |
| Feb 5, 2021 | K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Re M/s. Meril Endo Surgery Private Limited., IN | GDW |
| Nov 23, 2020 | K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier M/s. Meril Endo Surgery Private Limited., IN | FZP |
| Feb 1, 2018 | K172146 | MERISTEEL M/s. Meril Endo Surgery Private Limited., IN | GAQ |
| Oct 20, 2017 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON X M/s. Meril Endo Surgery Private Limited., IN | GAP |
| Sep 28, 2017 | K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MI M/s. Meril Endo Surgery Private Limited., IN | GAM |
| May 31, 2016 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON X M/s. Meril Endo Surgery Private Limited., IN | GAP |
| Oct 14, 2015 | K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron M/s. Meril Endo Surgery Private Limited., IN | GAM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||