ULTRA Telescopes
by Olympus Winter & Ibe GmbH 3 variants
510(k) K150633
ULTRA Telescopes is a medical device (FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K150633 on 29 Apr 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150633 | Date29 Apr 2015 | StatusActive |
Official records
- FDA 510(k) database K150633
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K150633
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Olympus WA4KL100 | WA4KL100 / WA4KL100 | 04042761082846 | — | On the market |
| Olympus WA4KL130 | WA4KL130 / WA4KL130 | 04042761082853 | — | On the market |
| Olympus WA4KL145 | WA4KL145 / WA4KL145 | 04042761082860 | — | On the market |
| Olympus WA4KL500 | WA4KL500 / WA4KL500 | 04042761082877 | — | On the market |
| Olympus WA4KL530 | WA4KL530 / WA4KL530 | 04042761082884 | — | On the market |
| Olympus WA4KL545 | WA4KL545 / WA4KL545 | 04042761082891 | — | On the market |
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Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).
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