Hem-O-Lok -- Modification
FDA 510(k) K922186 · Linvatec Corp.
510(k) numberK922186
Submission
- Device name
- Hem-O-Lok -- Modification
- Applicant
- Linvatec Corp.
Research Triangle Pa, NC, US - Received
- February 27, 1992
- Decision date
- August 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
More from Ethicon Endo-Surgery
| 510(k) | Device | Decision |
|---|---|---|
| K092998 | Conmed Linvatec Intercept ImplantMBI · Traditional | 12/23/2009SE |
| K091549 | Conmed Linvatec Soft Tissue to Bone SystemMBI · Special | 06/23/2009SE |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRMAI · Traditional | 06/22/2009SE |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi SuturesMAI · Special | 04/10/2009SE |
| K083281 | El Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…GEI · Traditional | 02/25/2009SE |
| K060198 | Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…HRX · Special | 05/11/2006SE |
| K060270 | Micropower Hand Piece: Oral Max High Speed DrillDZI · Special | 04/10/2006SE |
| K060260 | Micropower Hand Piece High Speed DrillHBC · Special | 04/10/2006SE |
| K050519 | Advanced Turbo Drive SystemGEY · Special | 05/17/2005SE |
| K050497 | Bioscrew Xtralok, 8X35MM & 8X40MM VioletHWC · Special | 03/25/2005SE |
Questions and answers
When was Hem-O-Lok -- Modification cleared by the FDA?
Hem-O-Lok -- Modification (K922186) received a 510(k) decision of Substantially Equivalent on August 6, 1992, 161 days after the submission was received.
What is the product code of K922186?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.