Marlow Anal Speculum
FDA 510(k) K891352 · Simpson/Basye, Inc.
510(k) numberK891352
Submission
- Device name
- Marlow Anal Speculum
- Applicant
- Simpson/Basye, Inc.
Wilmington, DE, US - Received
- March 10, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOA – Surgical Instruments, G-U, Manual (And Accessories)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182664 | FiXcisionKOA · Traditional | Agency For Medical Innovations GmbH | 12/07/2018SE |
| K950267 | Urethral Suture GuideKOA · Traditional | Applied Medical Resources | 01/31/1995SE |
| K932465 | Li VasectomyKOA · Traditional | Femcare , Ltd. | 03/02/1994SE |
| K921546 | Vasovasostomy SetKOA · Traditional | Cook Urological, Inc. | 07/02/1993SESK |
| K931181 | Vesitec Suture PasserKOA · Traditional | Vesitec Medical, Inc. | 05/12/1993SE |
| K921304 | DDV LigatorKOA · Traditional | North American Medical, Inc. | 10/05/1992SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | Pilling Co. | 09/23/1992SE |
| K921228 | Benderev Protect-A-Pass NeedleKOA · Traditional | Eimark Labs, Inc. | 09/14/1992SE |
| K922192 | Vas DilatorKOA · Traditional | Cook Urological, Inc. | 08/07/1992SE |
| K896058 | Grasping ForcepsKOA · Traditional | Annex Medical, Inc. | 12/28/1989SE |
More from Annex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926179 | Sedlacek HandleHGI · Traditional | 03/25/1994SE |
| 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 |
| 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 Marlow Anal Speculum cleared by the FDA?
Marlow Anal Speculum (K891352) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 105 days after the submission was received.
What is the product code of K891352?
The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.