Newport Lateral Vaginal Retractor
FDA 510(k) K891351 · Simpson/Basye, Inc.
510(k) numberK891351
Submission
- Device name
- Newport Lateral Vaginal Retractor
- Applicant
- Simpson/Basye, Inc.
Wilmington, DE, US - Received
- March 10, 1989
- Decision date
- May 11, 1989
- 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
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| 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 |
| 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 |
| K812204 | Uterine ManipulatorsKOH · Traditional | Reznik Instruments | 10/13/1981SE |
More from Reznik Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K926179 | Sedlacek HandleHGI · Traditional | 03/25/1994SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | 06/23/1989SE |
| K891350 | Newport Cervical ManipulatorHDC · Traditional | 03/29/1989SE |
| K891349 | Campion Cervical HookHDC · Traditional | 03/29/1989SE |
| K891347 | Reid Endocervical SpreaderHDC · 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 Newport Lateral Vaginal Retractor cleared by the FDA?
Newport Lateral Vaginal Retractor (K891351) received a 510(k) decision of Substantially Equivalent on May 11, 1989, 62 days after the submission was received.
What is the product code of K891351?
The FDA product code is KOH – Instrument, Manual, General Obstetric-Gynecologic, a Class I (low risk) device regulated under 21 CFR 884.4520.