Forceps, Biopsy, Non-Electric, Reprocessed

NON · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1075

Classification

FDA Product Code: NON
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.1075
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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).

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown