FHQ · Holder, Needle, Gastroenterologic
Gastroenterology, Urology · 21 CFR 876.4730 · Class 1
Overview
| Product Code | FHQ |
|---|---|
| Device Name | Holder, Needle, Gastroenterologic |
| 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 |
|---|---|---|---|---|
| K974327 | WINGED NEEDLE HOLDER | Phx Technologies Corp. | Jan 9, 1998 | SESE |
| K924196 | LAPAROSCOPIC NEEDLE HOLDER | Nusurg, Inc. | Jun 25, 1993 | SESE |
| K930330 | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | Holmed Corp. | Jun 8, 1993 | SESE |
| K920706 | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | Retrax | May 26, 1993 | SESE |
| K851780 | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | Artiberia | Jun 20, 1985 | SESE |
| K851779 | 25-100,25-220 VARIOUS NEEDLE HOLDERS | Artiberia | Jun 20, 1985 | SESE |
| K771859 | NEEDLE HOLDER, MICROVASCULAR | Edward Weck, Inc. | Oct 4, 1977 | SESE |
Top Applicants
- Artiberia — 2 clearances
- Retrax — 1 clearance
- Phx Technologies Corp. — 1 clearance
- Nusurg, Inc. — 1 clearance
- Holmed Corp. — 1 clearance
