Aed Cystoscope
by National Advanced Endoscopy Devices, Inc.
510(k) K993689
Aed Cystoscope is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K993689 on 15 Dec 1999, 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 | NumberK993689 | Date15 Dec 1999 | StatusActive |
Official records
- FDA 510(k) database K993689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FAJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K993689
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 22-2701 | 22-2701 | 00848657006453 | — | On the market |
| AED 22-2822 | 22-2822 | 00848657006460 | — | On the market |
| AED 26068 CD | 26068 CD | 00848657011198 | — | On the market |
| AED 27026CA | 27026CA | 00848657015615 | — | No longer on the market |
| AED 27072F | 27072F | 00848657015639 | — | No longer on the market |
| AED 27502 | 27502 | 00848657014151 | — | No longer on the market |
| AED 27502-AED | 27502-AED | 00848657013871 | — | No longer on the market |
| AED 32-4055 | 32-4055 | 00848657019446 | — | On the market |
| AED 32-4056 | 32-4056 | 00848657019453 | — | On the market |
| AED 32-4057 | 32-4057 | 00848657019460 | — | On the market |
| AED 32-4065 | 32-4065 | 00848657019484 | — | On the market |
| AED 32-4068 | 32-4068 | 00848657019514 | — | On the market |
| AED 32-4072 | 32-4072 | 00848657019569 | — | On the market |
| AED 32-4075 | 32-4075 | 00848657019545 | — | On the market |
| AED 32-4085-A-SET | 32-4085-A-SET | 00848657013291 | — | On the market |
| AED 32-4087 | 32-4087 | 00848657019590 | — | On the market |
| AED 32-4090 | 32-4090 | 00848657019552 | — | On the market |
| AED 32-4095 | 32-4095 | 00848657019668 | — | On the market |
| AED 32-4100 | 32-4100 | 00848657013062 | — | On the market |
| AED 32-4110 | 32-4110 | 00848657019675 | — | On the market |
| AED 32-4211 | 32-4211 | 00848657019927 | — | On the market |
| AED 32-4222 | 32-4222 | 00848657014021 | — | On the market |
| AED 32-4375 | 32-4375 | 00848657014007 | — | On the market |
| AED 324205RR | 324205RR | 00848657021432 | — | On the market |
| AED 324221RR | 324221RR | 00848657021951 | — | On the market |
| AED 4135PF | 4135PF | 00848657012348 | — | On the market |
| AED 57012 | 57012 | 00848657084925 | — | On the market |
| AED 5705F | 5705F | 00848657012843 | — | On the market |
| AED 5727B-L | 5727B-L | 00848657019422 | — | On the market |
| AED 5727W-L | 5727W-L | 00848657019415 | — | On the market |
| AED 67161FZ | 67161FZ | 00848657069250 | — | On the market |
| AED 8805C-OLY STYLE - A22003A CYSTOSCOPE | 8805C-OLY / 8805C-OLY | 00848657074360 | — | On the market |
| AED A24121-47 | A24121-47 | 00848657078191 | — | On the market |
| AED A24131-47 | A24131-47 | 00848657076692 | — | On the market |
| AED AED11275FE | AED11275FE | 00848657023122 | — | On the market |
| AED AED27023ZE | AED27023ZE | 00848657078160 | — | On the market |
| AED E153 | E153 | 00848657021869 | — | On the market |
| AED EMRS-24B | EMRS-24B | 00848657015356 | — | On the market |
| AED F/W URT | F/W URT | 00848657021517 | — | On the market |
| AED FG30C | FG30C | 00848657086936 | — | On the market |
| AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cm FG1075 | FG1075 / FG1075 | 00848657076159 | — | On the market |
| AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cm FS1055 | FS1055 / FS1055 | 00848657076166 | — | On the market |
| AED Gold Cystoscope 4mm x 0 Degree Olympus Mount 8805A-OLY | 8805A-OLY / 8805A-OLY | 00848657075145 | — | On the market |
| AED Gold Cystoscope 4mm x 12 Degree Olympus Mount 8805F-OLY | 8805F-OLY / 8805F-OLY | 00848657075152 | — | On the market |
| AED M2700 | M2700 / M2700 | 00848657078375 | — | On the market |
| AED U5780 | U5780 | 00848657076616 | — | On the market |
| AED27050VL 7Fr Laser Bridge | AED27050VL / AED27050VL | 00848657075169 | — | On the market |
| STORZ (STYLE) CYSTO SHEATH 17FR 32-4070-STZ | 32-4070-STZ / 32-4070-STZ | 00848657019132 | — | On the market |
| STORZ (STYLE) CYSTO SHEATH 22FR 32-4085-STZ | 32-4085-STZ / 32-4085-STZ | 00848657019194 | — | On the market |
| STORZ (STYLE) CYSTO SHEATH 25FR 32-4090-STZ | 32-4090-STZ / 32-4090-STZ | 00848657021418 | — | On the market |
Similar devices
Other devices filed under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid).
- ENDO SMARTCAP 100551 by MEDIVATORS INC.
- HOPKINS 26020FA by Karl Storz SE & CO. KG
- HOPKINS 27324AA by Karl Storz SE & CO. KG
- Luminelle DTx Hysteroscopy System by Uvision360, Inc.
- LUMINELLE DTx System by Uvision360, Inc.
- UROLIFT ® UL-GRASP-R by SCHÖLLY FIBEROPTIC GmbH
- OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES by Optus, Inc.
- TIP, RUBBER, PERFORATED by V. Mueller O.V. Baxter Healthcare Corp.
- Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath by Henke-Sass, Wolf GmbH
- Endosee Advance Cannula with Pipet ESPX5 by CooperSurgical, Inc.
Other devices from National Advanced Endoscopy Devices, Inc.
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