510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NONClass I

Forceps, Biopsy, Non-Electric, Reprocessed

21 CFR 876.1075 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NON is the FDA product code for Forceps, Biopsy, Non-Electric, Reprocessed, a class I device type, regulated under 21 CFR 876.1075. FDA's definition for this code reads: "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)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NON
Device name
Forceps, Biopsy, Non-Electric, Reprocessed
FDA definition
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).
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
1

Clearances, product code NON

By decision year
3 clearances under product code NON with a decision year between 2005 and 2005, 2005 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NON by decision year
YearClearances
20053

Applicants with the most clearances

Product code NON
Applicants holding the most 510(k) clearances under product code NON
ApplicantClearances
Medisiss1
Sterilmed Inc1
Stryker Sustainability Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code