Instrument Curnett Mini-Coner Biopsy
FDA 510(k) K781767 · C.R. Bard, Inc.
510(k) numberK781767
Submission
- Device name
- Instrument Curnett Mini-Coner Biopsy
- Applicant
- C.R. Bard, Inc.
Mchenry, IL, US - Received
- October 16, 1978
- Decision date
- December 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOH – Instrument, Manual, General Obstetric-Gynecologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000212 | Ksea Chardonnes Morcellation KnifeKOH · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/21/2000SE |
| K921732 | Minor Lap SetKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K921730 | C-Section PackKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K892693 | Vaginal Specula: Cusco, Guttman, InfantKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 05/11/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | Simpson/Basye, Inc. | 05/11/1989SE |
| K891035 | Needle ExtensionsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K891049 | Zeppelin ScissorsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K863610 | The Ob-Gyn Concepts Vaginal AspiratorKOH · Traditional | Ob/Gyn Concepts, Ltd. | 01/07/1987SE |
| K840308 | Cat. 4-OBSTETRICS Gynecology Dev'sKOH · Traditional | Imm Enterprises , Ltd. | 03/05/1984SE |
| K823792 | Quartz Retractor/ProbeKOH · Traditional | American V. Mueller | 01/18/1983SE |
More from American V. Mueller
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Instrument Curnett Mini-Coner Biopsy cleared by the FDA?
Instrument Curnett Mini-Coner Biopsy (K781767) received a 510(k) decision of Substantially Equivalent on December 7, 1978, 52 days after the submission was received.
What is the product code of K781767?
The FDA product code is KOH – Instrument, Manual, General Obstetric-Gynecologic, a Class I (low risk) device regulated under 21 CFR 884.4520.