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

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

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

QHC is the FDA product code for Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs, a class II device type, regulated under 21 CFR 876.1075. FDA's definition for this code reads: "Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QHC
Device name
Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs
FDA definition
Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QHC.