V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (Tm)...
FDA 510(k) K111442 · Covidien, Formerly US Surgical A Divison of Tyco H
510(k) numberK111442
Submission
- Device name
- V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (Tm)...
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
North Haven, CT, US - Received
- May 24, 2011
- Decision date
- June 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K131705 | Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Special | 07/01/2013SE |
| K130532 | Idrive Ultra Sterilization TrayKCT · Traditional | 05/30/2013SE |
| K130717 | Endo Gia ReloadGDW · Special | 04/18/2013SE |
| K130435 | Versaport V2 Bladeless Optical TrocarGCJ · Special | 03/14/2013SE |
| K122781 | Reliamax Gastrointestinal Anastomosis and ReloadGDW · Traditional | 02/05/2013SE |
| K123318 | Idrive Ultra Powered Handle and Endo Gia AdapterGDW · Special | 12/18/2012SE |
| K121510 | Idrive Ultra Powered Handle Endo Gia AdapterGDW · Traditional | 07/25/2012SE |
| K120061 | Wound ProtectorGCJ · Traditional | 03/27/2012SE |
| K120258 | Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…GDW · Traditional | 02/29/2012SE |
| K111825 | Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) StaplersGDW · Traditional | 10/25/2011SE |
Questions and answers
When was V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (Tm)... cleared by the FDA?
V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (Tm)... (K111442) received a 510(k) decision of Substantially Equivalent on June 3, 2011, 10 days after the submission was received.
What is the product code of K111442?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.