Disposable Multiple Ligating Clip
FDA 510(k) K820837 · ETHICON, Inc.
510(k) numberK820837
Submission
- Device name
- Disposable Multiple Ligating Clip
- Applicant
- ETHICON, Inc.
Mchenry, IL, US - Received
- March 26, 1982
- Decision date
- May 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDO – Applier, Surgical, Clip
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926199 | Uniclip Surgical Clip ApplierGDO · Traditional | Unisurge, Inc. | 04/20/1993SE |
| K890941 | Modified Suture Disp. Endoscopic Surgical Clip AppGDO · Traditional | United States Surgical, A Division of Tyco Healthc | 04/07/1989SE |
| K890159 | Towel ClipsGDO · Traditional | Dhason Brothers, Inc. | 02/03/1989SE |
| K890233 | Suture Clip Applier/RemoverGDO · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K812291 | Ethicon Multiple Ligating Clip ApplierGDO · Traditional | ETHICON, Inc. | 09/11/1981SE |
| K792378 | Hemospenser Cartridge Cat. No. 523500-GDO · Traditional | Edward Weck, Inc. | 12/06/1979SE |
| K791845 | Bayonet Heifetz Clip AppliersGDO · Traditional | Edward Weck, Inc. | 10/17/1979SE |
| K790855 | Surgical Drape Clip #201GDO · Traditional | C. Intl. | 08/03/1979SE |
| K791157 | 360 Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/27/1979SE |
| K790990 | Reynolds Double Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/05/1979SE |
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Questions and answers
When was Disposable Multiple Ligating Clip cleared by the FDA?
Disposable Multiple Ligating Clip (K820837) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 63 days after the submission was received.
What is the product code of K820837?
The FDA product code is GDO – Applier, Surgical, Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.