Middle Ear Picks, Hooks Curettes,
FDA 510(k) K791120 · Xomed, Inc.
510(k) numberK791120
Submission
- Device name
- Middle Ear Picks, Hooks Curettes,
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- June 15, 1979
- Decision date
- July 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDG – Hook, Surgical, 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 GDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900069 | Modified PGL Absorbable Staple*GDG · Traditional | United States Surgical, A Division of Tyco Healthc | 04/16/1990SE |
| K891898 | Skin Hooks, Various TypesGDG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | Cedar Surgical, Inc. | 12/12/1986SE |
| K843136 | Brimfield Cannulated Grasping HooksGDG · Traditional | Brimfield Scientific Instruments | 09/25/1984SE |
| K841010 | Surgical Hooks, VariousGDG · Traditional | Premier Dental Products Co. | 05/01/1984SE |
| K812562 | Surgical Retractor & Elastic Stays, DispGDG · Traditional | Humboldt Products | 10/02/1981SE |
| K780289 | Nerve ApproximaterGDG · Traditional | Edward Weck, Inc. | 06/14/1978SE |
| K771190 | Abramson Trachea Hook & RetractorGDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K771187 | Dermahook #382-805GDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
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| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
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| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
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Questions and answers
When was Middle Ear Picks, Hooks Curettes, cleared by the FDA?
Middle Ear Picks, Hooks Curettes, (K791120) received a 510(k) decision of Substantially Equivalent on July 10, 1979, 25 days after the submission was received.
What is the product code of K791120?
The FDA product code is GDG – Hook, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.