Tischler Biopsy Forceps
FDA 510(k) K926538 · Thomasville Medical Assoc.
510(k) numberK926538
Submission
- Device name
- Tischler Biopsy Forceps
- Applicant
- Thomasville Medical Assoc.
Alpharetta, GA, US - Received
- December 30, 1992
- Decision date
- February 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K924224 | Owens Biopsy ForcepsHFB · Traditional | Owens Precision Systems, Inc. | 02/04/1994SE |
| K902049 | Croak Ovarian Biopsy ForcepHFB · Traditional | Gynescope Corp. | 06/07/1990SE |
| K895303 | Ever-Sharp Biopsy ForcepsHFB · Traditional | Southwest Medical Mfg., Inc. | 01/16/1990SE |
More from Southwest Medical Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926429 | Vaginal Specula: Cusco, Guttman, InfantHDF · Traditional | 02/28/1994SE |
| K930030 | Suction Tubes: House, BaronJCX · Traditional | 02/25/1994SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | 02/25/1994SE |
| K926536 | Disposable Plastic Vaginal SpeculaHIB · Traditional | 02/25/1994SE |
| K926535 | Gomco Circumcision ClampHFX · Traditional | 02/25/1994SE |
| K926533 | Z-Clamp ForcepsHCZ · Traditional | 02/25/1994SE |
| K926532 | Endo Cervical CuretteKNA · Traditional | 02/25/1994SE |
| K926531 | Hysterectomy ForcepsHCZ · Traditional | 02/25/1994SE |
| K926527 | Roto Fit Biopsy ForcepsHFB · Traditional | 02/25/1994SE |
| K926484 | Corson Myoma Grasping ForcepsHCZ · Traditional | 02/25/1994SE |
Questions and answers
When was Tischler Biopsy Forceps cleared by the FDA?
Tischler Biopsy Forceps (K926538) received a 510(k) decision of Substantially Equivalent on February 24, 1994, 421 days after the submission was received.
What is the product code of K926538?
The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.