Reprocessed Cold Biopsy Forceps

FDA 510(k) K042648 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK042648

Submission

Device name
Reprocessed Cold Biopsy Forceps
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
September 28, 2004
Decision date
July 20, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NON – Forceps, Biopsy, Non-Electric, Reprocessed
Device class
Class I (low risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NON

510(k)DeviceApplicantDecision
K042659Medisiss Reprocessed Non-Electric Gi Biopsy ForcepsNON · Traditional Medisiss02/14/2005SE
K042594Vanguard Reprocessed Non-Electric Biopsy ForcepsNON · Traditional Vanguard Medical Concepts, Inc.01/25/2005SE

More from Vanguard Medical Concepts, Inc.

510(k)DeviceDecision
K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional 06/29/2026SE
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional 10/11/2024SE
K190478Reprocessed ViewFlex™ Xtra ICE CatheterOWQ · Traditional 11/14/2019SE
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional 08/15/2019SE
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional 04/15/2019SE
K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional 11/21/2016SE
K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional 09/20/2016SE
K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional 06/23/2016SE
K152090Reprocessed Steerable IntroducerPNE · Traditional 03/23/2016SE
K152134Reprocessed Vessel SealerNUJ · Traditional 01/15/2016SE

Questions and answers

When was Reprocessed Cold Biopsy Forceps cleared by the FDA?

Reprocessed Cold Biopsy Forceps (K042648) received a 510(k) decision of Substantially Equivalent on July 20, 2005, 295 days after the submission was received.

What is the product code of K042648?

The FDA product code is NON – Forceps, Biopsy, Non-Electric, Reprocessed, a Class I (low risk) device regulated under 21 CFR 876.1075.