Ascep, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Ascep, Inc. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ascep, Inc." is on file.

What these totals cover: FDA records filed under the name "Ascep, Inc." and its spelling variant "Ascep".

Latest 510(k)
Apr 12, 1983

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances9Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) clearances

9 510(k) clearances from Oct 17, 1979 to Apr 12, 1983.

K-NumberDeviceDate
K830219VARIOUS INSTRUMENTS & INSTRUMENT TRAYSApr 12, 1983
K822893G.E.V. DISPOSABLE SCALPELSOct 22, 1982
K810004STERILE DISPOSABLE INSTRUMENT TRAYSJan 26, 1981
K802726INSTRUMENTS NONSTERILE & STERILENov 19, 1980
K791886I.V. CARE KITOct 26, 1979
K791885I.V. START SETOct 22, 1979
K791887CENTRAL VENOUS CATHETER DRESSING TRAYOct 17, 1979
K791888CATHETER CARE KIT REORDER 7940&7941Oct 17, 1979
K791889SUTURE REMOVAL TRAY, REORDER 7950&7951Oct 17, 1979

Ascep, Inc. and the FDA: common questions

Has Ascep, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ascep, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ascep, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ascep, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.