Kevorkian-Younge Biopsy Curette #90-6611
FDA 510(k) K802458 · J. Sklar Mfg. Co., Inc.
510(k) numberK802458
Submission
- Device name
- Kevorkian-Younge Biopsy Curette #90-6611
- Applicant
- J. Sklar Mfg. Co., Inc.
Mchenry, IL, US - Received
- October 8, 1980
- Decision date
- January 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFB – Forceps, Biopsy, Gynecological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011488 | Spirabrush CX Biopsy InstrumentHFB · Traditional | Trylon Corp. | 02/22/2002SE |
| K944444 | Cit Biopsy PunchesHFB · Traditional | Chirurgische Instrumente | 09/29/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | Symbiosis Corp. | 07/28/1994SE |
| K933767 | Forceps, Biopsy Gynecological Instru/BiopsyHFB · Traditional | Mahe-Medizintechnik | 05/26/1994SE |
| K926595 | Owens Biopsy ForcepsHFB · Traditional | Owens Industries, Inc. | 05/25/1994SE |
| K926527 | Roto Fit Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K930036 | Thomas Medical Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K926538 | Tischler Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K924224 | Owens Biopsy ForcepsHFB · Traditional | Owens Precision Systems, Inc. | 02/04/1994SE |
| K902049 | Croak Ovarian Biopsy ForcepHFB · Traditional | Gynescope Corp. | 06/07/1990SE |
More from Gynescope Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K843693 | Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional | 10/31/1984SE |
| K842112 | Tischler Cervical Biopsy Punch ForcepsHFB · Traditional | 07/03/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | 06/19/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | 09/14/1982SE |
| K802457 | Kevorkian-Younge Biopsy Punch, #90-6610HFB · Traditional | 01/12/1981SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | 04/08/1980SE |
| K790577 | Hemorrhoidal LigatorHCF · Traditional | 04/23/1979SE |
| K772230 | Cannula, Perfusion, Fallopian TubeLKF · Traditional | 01/03/1978SE |
| K772229 | Miniclamps, Stabiliz., Fallopian TubeHCZ · Traditional | 01/03/1978SE |
Questions and answers
When was Kevorkian-Younge Biopsy Curette #90-6611 cleared by the FDA?
Kevorkian-Younge Biopsy Curette #90-6611 (K802458) received a 510(k) decision of Substantially Equivalent on January 12, 1981, 96 days after the submission was received.
What is the product code of K802458?
The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.