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

Appendiceal Scope And Accessories, Flexible

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

SHU is the FDA product code for Appendiceal Scope And Accessories, Flexible, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHU
Device name
Appendiceal Scope And Accessories, Flexible
FDA definition
Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.
Regulation
21 CFR 876.1500
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
1
Ingested recalls
0

Clearances, product code SHU

By decision year
1 clearance under product code SHU with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHU by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHU
Applicants holding the most 510(k) clearances under product code SHU
ApplicantClearances
Micro-Tech (Nanjing) Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code