Cavermap Surgical Aid
FDA 510(k) K993436 · Uromed Corp.
510(k) numberK993436
Submission
- Device name
- Cavermap Surgical Aid
- Applicant
- Uromed Corp.
Norwood, MA, US - Received
- October 12, 1999
- Decision date
- February 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGM – Probe And Director, Gastro-Urology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041732 | Cavermap Surgical AidFGM · Traditional | Blue Torch Medical Technologies | 09/21/2004SE |
| K031527 | Modification to Cavermap Surgical AidFGM · Special | Blue Torch Medical Technologies | 06/05/2003SE |
| K010098 | Modification to Cavermap Surgical AidFGM · Special | Uromed Corp. | 02/01/2001SE |
| K944384 | Orion's Urethral Catheterization Kit Without BagFGM · Traditional | Regulatory & Marketing Services, Inc. | 02/15/1995SE |
| K944379 | Orion's Foley Catheterization Kit with Catheter and BagFGM · Traditional | Regulatory & Marketing Services, Inc. | 02/15/1995SE |
| K944378 | Orion's Urethral Catheterization Kit with Catheter and BagFGM · Traditional | Regulatory & Marketing Services, Inc. | 02/15/1995SE |
More from Regulatory & Marketing Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010213 | Modification to Cavermap Surgical AidETN · Traditional | 04/20/2001SE |
| K010098 | Modification to Cavermap Surgical AidFGM · Special | 02/01/2001SE |
| K000507 | Cavermap Surgical AidETN · Traditional | 04/21/2000SE |
| K982226 | Uromed Brachytheraphy IODINE-125 SourcesKXK · Traditional | 05/13/1999SE |
| K980717 | Uromed Sling KitKNA · Traditional | 05/22/1998SE |
| K974600 | Uromed PatchMNG · Traditional | 03/31/1998SE |
| K974137 | Uromed Needle GrasperOCW · Traditional | 01/30/1998SE |
| K970971 | Uro Med Nerve StimulatorETN · Traditional | 10/27/1997SE |
| K971992 | Uromed Alternative Bladder Control Continence DEVICE(ABCPN-0026)FHA · Traditional | 08/01/1997SE |
Questions and answers
When was Cavermap Surgical Aid cleared by the FDA?
Cavermap Surgical Aid (K993436) received a 510(k) decision of Substantially Equivalent on February 11, 2000, 122 days after the submission was received.
What is the product code of K993436?
The FDA product code is FGM – Probe And Director, Gastro-Urology, a Class I (low risk) device regulated under 21 CFR 876.4730.