FGM · Probe And Director, Gastro-Urology
Gastroenterology, Urology · 21 CFR 876.4730 · Class 1
Overview
| Product Code | FGM |
|---|---|
| Device Name | Probe And Director, Gastro-Urology |
| Regulation | 21 CFR 876.4730 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041732 | CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | Sep 21, 2004 | SESE |
| K031527 | MODIFICATION TO CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | Jun 5, 2003 | SESE |
| K010098 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | Feb 1, 2001 | SESE |
| K993436 | CAVERMAP SURGICAL AID | Uromed Corp. | Feb 11, 2000 | SESE |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |
Top Applicants
- Regulatory & Marketing Services, Inc. — 3 clearances
- Uromed Corp. — 2 clearances
- Blue Torch Medical Technologies — 2 clearances
