Who is the manufacturer of RUNYON LARGE VOLUME PARACENTESIS KIT?

Gi Supply submitted the Traditional clearance for RUNYON LARGE VOLUME PARACENTESIS KIT (K970187).

What is the FDA product code for RUNYON LARGE VOLUME PARACENTESIS KIT?

LRO. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for RUNYON LARGE VOLUME PARACENTESIS KIT?

510(k) clearance (submission type: Traditional).

RUNYON LARGE VOLUME PARACENTESIS KIT

K970187 · Gi Supply · LRO · Feb 14, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970187
Device Name	RUNYON LARGE VOLUME PARACENTESIS KIT
Applicant	Gi Supply
Product Code	LRO · General, Plastic Surgery
Decision Date	Feb 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.