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

Laparoscopy Kit

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

FDE is the FDA product code for Laparoscopy Kit, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 121 recalls.

Classification record

Product code
FDE
Device name
Laparoscopy Kit
FDA definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
124

Clearances, product code FDE

By decision year
4 clearances under product code FDE with a decision year between 1991 and 1996, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FDE by decision year
YearClearances
19911
19941
19951
19961

Applicants with the most clearances

Product code FDE
Applicants holding the most 510(k) clearances under product code FDE
ApplicantClearances
Aslan Medical Technologies, Ltd.1
Boston Scientific Corporation1
Candela Corporation1
Mitsubishi Cable America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order