Disposable Bipolar Forceps
FDA 510(k) K873978 · E.M. Adams
510(k) numberK873978
Submission
- Device name
- Disposable Bipolar Forceps
- Applicant
- E.M. Adams
Medfield, MA, US - Received
- September 30, 1987
- Decision date
- November 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEN – Forceps, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900951 | GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
More from Zinnanti Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K971536 | Restraints (Vests and Jackets)FMQ · Traditional | 07/01/1997SE |
| K905173 | Splash GuardKYZ · Traditional | 04/25/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843783 | Wet PackEFQ · Traditional | 12/19/1984SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843723 | Sterile Instrument Trays-VariousFSM · Traditional | 10/23/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | 09/07/1984SE |
Questions and answers
When was Disposable Bipolar Forceps cleared by the FDA?
Disposable Bipolar Forceps (K873978) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 54 days after the submission was received.
What is the product code of K873978?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.