Medicon Instruments Cholangiography Needles, Guide Tubes, Injection Needles, Verres Insufflation Needles and Holders
K936248 is the FDA 510(k) clearance record for MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS, a class II device, cleared for Medicon Instruments, Inc. on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 6 510(k) clearances for Medicon Instruments, Inc., from to . As of , FDA records show no recalls naming K936248.
Clearance record
- Decision date
- Received
- (137 days to decision)
- Product code
- GCJ Laparoscope, General & Plastic Surgery
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Applicant
- Medicon Instruments, Inc. Colubmia Sq., Washington DC
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code GCJ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 0 |
| January 2026 | 3 |
| February 2026 | 4 |
| March 2026 | 0 |
| April 2026 | 3 |
| May 2026 | 4 |
| June 2026 | 4 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 2 |
| October 2026 | 0 |
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