STEERABLE CATHETER SYSTEM
FDA 510(k) clearance K862424 · decided 1986-09-22
Clearance details
- K-number
- K862424
- Device name
- STEERABLE CATHETER SYSTEM
- Applicant
- Endovations
- Decision
- Substantially Equivalent
- Date received
- 1986-06-26
- Decision date
- 1986-09-22
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GCP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Camp Hill, PA, 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 |
| 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 |
| ENDOSCOPE AND ACCESSORIES (K790071) | Olympus Corp. | 1979-04-02 |
| 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
No recalls on record reference this clearance.