AED Arthroscope
by National Advanced Endoscopy Devices, Inc.
510(k) K991656
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991656 | Date2 Dec 1999 | StatusActive |
Official records
- FDA 510(k) database K991656
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
An arthroscope is a device used for visualizing, diagnosing, and treating conditions within a joint. The AED Arthroscope is an orthopedic endoscopic instrument designed for use in arthroscopic procedures.
It is supplied as a reusable device intended for use in clinical settings such as operating rooms or outpatient surgical centers. The device received FDA 510(k) clearance (K991656) as substantially equivalent to a legally marketed predicate device, with review by the Orthopedic advisory committee.
Devices cleared under K991656
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 | |||
|---|---|---|---|---|
| AED 5700A-S | 5700A-S | 00848657014229 | — | On the market |
| AED 5700A-STZ | 5700A-STZ | 00848657074520 | — | On the market |
| AED 5700A-V | 5700A-V | 00848657014038 | — | On the market |
| AED 5700B-DYA | 5700B-DYA | 00848657077583 | — | On the market |
| AED 5700B-DYA | 5700B-DYA | 00848657071437 | — | No longer on the market |
| AED 5700B-OLY | 5700B-OLY | 00848657077224 | — | On the market |
| AED 5700B-OLY | 5700B-OLY | 00848657072380 | — | No longer on the market |
| AED 5700B-S | 5700B-S | 00848657019309 | — | On the market |
| AED 5700B-STK | 5700B-STK | 00848657074636 | — | On the market |
| AED 5700B-STZ | 5700B-STZ | 00848657074537 | — | On the market |
| AED 5700B-V | 5700B-V | 00848657019316 | — | On the market |
| AED 5700B-V-DYA | 5700B-V-DYA | 00848657071451 | — | On the market |
| AED 5700B-V-STK | 5700B-V-STK | 00848657074667 | — | On the market |
| AED 5700B-WLF | 5700B-WLF | 00848657074711 | — | On the market |
| AED 5700C-S | 5700C-S | 00848657019323 | — | On the market |
| AED 5700C-STZ | 5700C-STZ | 00848657074544 | — | On the market |
| AED 5700C-V | 5700C-V | 00848657019330 | — | On the market |
| AED 5700F-S | 5700F-S | 00848657019347 | — | On the market |
| AED 5700F-V | 5700F-V | 00848657019354 | — | On the market |
| AED 5700W-S | 5700W-S | 00848657019361 | — | On the market |
| AED 5700W-V | 5700W-V | 00848657019378 | — | On the market |
| AED 5727B-STZ | 5727B-STZ | 00848657074513 | — | On the market |
| AED 70159 | 70159 | 00848657077668 | — | On the market |
| AED 70159 | 70159 | 00848657070812 | — | No longer on the market |
| AED 8800A-A | 8800A-A | 00848657077354 | — | On the market |
| AED 8800A-A | 8800A-A | 00848657087230 | — | No longer on the market |
| AED 8800B-A | 8800B-A | 00848657087261 | — | No longer on the market |
| AED 8800B-A | 8800B-A | 00848657077316 | — | On the market |
| AED 8800C-A | 8800C-A | 00848657077286 | — | On the market |
| AED 8800C-A | 8800C-A | 00848657087285 | — | No longer on the market |
| AED 8800F-A | 8800F-A | 00848657087308 | — | No longer on the market |
| AED 8800F-A | 8800F-A | 00848657077262 | — | On the market |
| AED 8827A-A | 8827A-A | 00848657087353 | — | On the market |
| AED 8827AS | 8827AS | 00848657087377 | — | On the market |
| AED 8827B-A | 8827B-A | 00848657087391 | — | On the market |
| AED 8827BS-A | 8827BS-A | 00848657087414 | — | On the market |
| AED Arthroscope 3mm x 0 degree, 175mm 8830A-A | 8830A-A / 8830A-A | 00848657023153 | — | On the market |
| AED Arthroscope 3mm x 30 degrees, 175mm 8830B-A | 8830B-A / 8830B-A | 00848657023146 | — | On the market |
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