Ever-Sharp Biopsy Forceps
FDA 510(k) K895303 · Southwest Medical Mfg., Inc.
510(k) numberK895303
Submission
- Device name
- Ever-Sharp Biopsy Forceps
- Applicant
- Southwest Medical Mfg., Inc.
Marietta, GA, US - Received
- August 29, 1989
- Decision date
- January 16, 1990
- 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 |
|---|---|---|
| K922243 | E-Z CLAMP#1 AND#2GCJ · Traditional | 07/14/1992SE |
Questions and answers
When was Ever-Sharp Biopsy Forceps cleared by the FDA?
Ever-Sharp Biopsy Forceps (K895303) received a 510(k) decision of Substantially Equivalent on January 16, 1990, 140 days after the submission was received.
What is the product code of K895303?
The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.