Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers
FDA 510(k) K950639 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK950639
Submission
- Device name
- Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- February 13, 1995
- Decision date
- June 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOK – Vaginoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220969 | GelPOINT V-Path Vaginal Access SystemMOK · Traditional | Applied Medical Resources Corporation | 09/16/2022SE |
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| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers cleared by the FDA?
Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers (K950639) received a 510(k) decision of Substantially Equivalent on June 19, 1995, 126 days after the submission was received.
What is the product code of K950639?
The FDA product code is MOK – Vaginoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 884.1630.