Submission Details
| 510(k) Number | K031527 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2003 |
| Decision Date | June 05, 2003 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO CAVERMAP SURGICAL AID
Jun 2003
Decision
21d
Days
Class 1
Risk
About This 510(k) Submission
K031527 is an FDA 510(k) clearance for the MODIFICATION TO CAVERMAP SURGICAL AID, a Probe And Director, Gastro-urology (Class I — General Controls, product code FGM), submitted by Blue Torch Medical Technologies (Newton, US). The FDA issued a Cleared decision on June 5, 2003, 21 days after receiving the submission on May 15, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
Device Classification
| Product Code | FGM — Probe And Director, Gastro-urology |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.4730 |
Manufacturer
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