Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
FDA 510(k) K150717 · M/s. Meril Endo Surgery Private Limited.
510(k) numberK150717
Submission
- Device name
- Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
- Applicant
- M/s. Meril Endo Surgery Private Limited.
Chala, Vapi, IN - Received
- March 19, 2015
- Decision date
- October 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4493
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/25/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | Medtronic | 05/28/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | ETHICON, Inc. | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | ETHICON, Inc. | 12/22/2025SE |
| K253620 | TroClose 1200GAM · Special | Gordian Surgical, Ltd. | 12/16/2025SE |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special | Internacional Farmacéutica S.A DE C.V | 10/03/2025SE |
| K233265 | Monotime and Optime RGAM · Abbreviated | Peters Surgical | 10/11/2024SE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated | Peters Surgical | 07/12/2024SE |
| K221527 | StitchKitGAM · Traditional | Origami Surgical Inc . | 02/14/2023SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 11/15/2022SE |
More from ETHICON, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | 09/23/2025SE |
| K233386 | Monik - Disposable Endoscopic TrocarGCJ · Traditional | 05/24/2024SE |
| K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…NEW · Traditional | 04/25/2024SE |
| K230981 | Meriglu Topical Skin AdhesiveMPN · Traditional | 03/16/2024SE |
| K200452 | Meril-BonewaxMTJ · Traditional | 03/27/2023SE |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…GDW · Traditional | 02/05/2021SE |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip ApplierFZP · Traditional | 11/23/2020SE |
| K172146 | MeristeelGAQ · Traditional | 02/01/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | 10/20/2017SE |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable…GAM · Special | 09/28/2017SE |
Questions and answers
When was Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron cleared by the FDA?
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron (K150717) received a 510(k) decision of Substantially Equivalent on October 14, 2015, 209 days after the submission was received.
What is the product code of K150717?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.