Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray

FDA 510(k) K955790 · Trylon Corp.

Substantially Equivalent

510(k) numberK955790

Submission

Device name
Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray
Applicant
Trylon Corp.
Monarch Beach, CA, US
Received
December 22, 1995
Decision date
March 21, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HIC – Speculum, Vaginal, Nonmetal, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIC

510(k)DeviceApplicantDecision
K923656Lighting Source SystemHIC · Traditional Galenica Enterprises, Inc.09/08/1994SE
K902516New Length Sugita AppliersHIC · Traditional Sims Surgical, Inc.07/03/1990SE
K897100Centurion Vaginal SpeculumHIC · Traditional Tri-State Hospital Supply Corp.03/16/1990SE
K853257Speculite Disposable Vaginal LightHIC · Traditional Trylon Associates, Ltd.12/27/1985SE

More from Trylon Associates, Ltd.

510(k)DeviceDecision
K033033Vizilite-Blue Oral Exam KitEAZ · Traditional 11/22/2004SE
K011488Spirabrush CX Biopsy InstrumentHFB · Traditional 02/22/2002SE
K012070Orallite Comprehensive Exam TrayMPU · Traditional 11/27/2001SE
K003995Speculite/OralliteEAZ · Traditional 03/16/2001SE
K963391SpeculiteMPU · Traditional 12/12/1997SE
K953364SpeculiteHET · Traditional 12/08/1995SE

Questions and answers

When was Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray cleared by the FDA?

Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray (K955790) received a 510(k) decision of Substantially Equivalent on March 21, 1996, 90 days after the submission was received.

What is the product code of K955790?

The FDA product code is HIC – Speculum, Vaginal, Nonmetal, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.