Sedlacek Handle
FDA 510(k) K926179 · Simpson/Basye, Inc.
510(k) numberK926179
Submission
- Device name
- Sedlacek Handle
- Applicant
- Simpson/Basye, Inc.
West Chester, PA, US - Received
- December 8, 1992
- Decision date
- March 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGI – Electrocautery, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4120
- Specialty
- Obstetrics/Gynecology
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|---|---|---|
| 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 |
| 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 Sedlacek Handle cleared by the FDA?
Sedlacek Handle (K926179) received a 510(k) decision of Substantially Equivalent on March 25, 1994, 472 days after the submission was received.
What is the product code of K926179?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.