Reid Endocervical Spreader
FDA 510(k) K891347 · Simpson/Basye, Inc.
510(k) numberK891347
Submission
- Device name
- Reid Endocervical Spreader
- Applicant
- Simpson/Basye, Inc.
Wilmington, DE, US - Received
- March 10, 1989
- Decision date
- March 29, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDC – Tenaculum, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223866 | Carevix Suction Cervical StabilizerHDC · Special | Aspivix SA | 01/25/2023SE |
| K203820 | ASPIVIX v1.1 Cervical Suction TenaculumHDC · Traditional | Aspivix SA | 08/17/2021SE |
| K142204 | Bioceptive Suction Cervical RetractorHDC · Traditional | Bioceptive, Inc. | 12/19/2014SE |
| K082349 | Jarit Hulka Uterine Tenaculum ForcepsHDC · Traditional | J. Jamner Surgical Instruments, Inc. | 11/21/2008SE |
| K073182 | Gyn Disposables Tenaculum 356THDC · Traditional | Gyn-Disposables, Inc. | 11/28/2007SE |
| K062563 | Femten Cervical TenaculumHDC · Traditional | Fem Suite, LLC | 05/18/2007SE |
| K060573 | Burbank TenaculumHDC · Traditional | Vascular Control Systems, Inc. | 04/21/2006SE |
| K032585 | Transvaginal Ultrasound Probe Holder SystemHDC · Special | Ron-Tech Medical , Ltd. | 01/09/2004SE |
| K030078 | Burbank Tenaculum, Model 09-0011-01HDC · Traditional | Vascular Control Systems, Inc. | 01/24/2003SE |
| K001818 | Uterine Tenaclum HookHDC · Traditional | Towne Brothers (Pvt.), Ltd. | 08/30/2000SE |
More from Towne Brothers (Pvt.), Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K926179 | Sedlacek HandleHGI · Traditional | 03/25/1994SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | 06/23/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | 05/11/1989SE |
| K891350 | Newport Cervical ManipulatorHDC · Traditional | 03/29/1989SE |
| K891349 | Campion Cervical HookHDC · Traditional | 03/29/1989SE |
| K891348 | Campion Laser ForcepsGEN · Traditional | 03/22/1989SE |
| K870276 | Heated Instrument BathLRJ · Traditional | 05/07/1987SE |
| K862717 | Hand Mirror (Endoscope)GCO · Traditional | 07/30/1986SE |
| K862629 | Surgical Laser Accessories (Sla) CaseFSM · Traditional | 07/17/1986SE |
| K790923 | Mi-Mark Endocervical Sampling SetKNA · Traditional | 06/22/1979SE |
Questions and answers
When was Reid Endocervical Spreader cleared by the FDA?
Reid Endocervical Spreader (K891347) received a 510(k) decision of Substantially Equivalent on March 29, 1989, 19 days after the submission was received.
What is the product code of K891347?
The FDA product code is HDC – Tenaculum, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.