ENDOSCOPE AND ACCESSORIES
FDA 510(k) clearance K790071 · decided 1979-04-02
Clearance details
- K-number
- K790071
- Device name
- ENDOSCOPE AND ACCESSORIES
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-11
- Decision date
- 1979-04-02
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GCP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EOS BRAND DISPOSABLE PROCTOSCOPE (K954614) | North Eos Industries, Inc. | 1996-04-10 |
| PORGES UNIVERSAL HANDLES (K896505) | Porges Corp. | 1990-01-30 |
| MODEL 6500 MERCURY ARC LIGHT SOURCE (K896008) | Medical Dynamics, Inc. | 1989-12-27 |
| STEERABLE CATHETER SYSTEM (K862424) | Endovations | 1986-09-22 |
| MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (K860103) | Endotherapeutics | 1986-02-12 |
| MODULAR FIBERSCOPE SYSTEM (K843683) | Reichert Scientific Instruments | 1985-01-18 |
| TAMPONADE BALLOON CUFF (K833859) | American Endoscopy, Inc. | 1984-01-03 |
| ENDOSCOPIC SCLEROTHERAPY BALLOON (K821999) | Retech | 1982-08-27 |
| CCD ENDOSCOPE AND ATTACHMENTS (K801247) | Welch Allyn, Inc. | 1980-07-28 |
| FIBER OPTICS SIGMOIDOSCOPE (K771919) | Propper Mfg. Co., Inc. | 1977-10-20 |
| FIBER OPTICS PROCTOSCOPE (K771920) | Propper Mfg. Co., Inc. | 1977-10-20 |
| FIBEO OPTICS ILLUM. SYSTEM (K771918) | Propper Mfg. Co., Inc. | 1977-10-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; recall (Z-1437-2026) | Olympus Corporation of the Americas | 2026-02-20 |
| Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urolog recall (Z-1454-2026) | Olympus Corporation of the Americas | 2026-02-20 |
| Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A S recall (Z-0351-2025) | Olympus Corporation of the Americas | 2024-11-08 |
| Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in recall (Z-1163-2010) | Olympus America Inc. | 2010-03-18 |