Instruments for Laparoscopy 5 Mm, 10 Mm with Coloured Handle, Detachable Endodcopic Instruments 5 Mm, 10Mm (Handle, Shaf
K003717 is the FDA 510(k) clearance record for INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF, a class II device, cleared for Tekno Medical Optik-Chirurgie GmbH & Co. on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI 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 2 510(k) clearances for Tekno Medical Optik-Chirurgie GmbH & Co., from to . As of , FDA records show no recalls naming K003717.
Clearance record
- Decision date
- Received
- (87 days to decision)
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Tekno Medical Optik-Chirurgie GmbH & Co. Unterer Winkel 3, Wurmlingen, DE
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code GEI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 4 |
| December 2025 | 1 |
| January 2026 | 6 |
| February 2026 | 3 |
| March 2026 | 5 |
| April 2026 | 5 |
| May 2026 | 4 |
| June 2026 | 9 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 5 |
| October 2026 | 0 |
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