EPY · Class I · 21 CFR 878.1800

FDA Product Code EPY: Speculum, Ent

Leading manufacturers include Edward Weck, Inc., Treace Medical, Inc. and Imm Enterprises , Ltd..

12
Total
12
Cleared
63d
Avg days
1978
Since

FDA 510(k) Cleared Speculum, Ent Devices (Product Code EPY)

12 devices
1–12 of 12
Cleared Dec 18, 1985
FIBRELIGHT NASAL SPECULA
K853588
Downs Surgical , Ltd.
General & Plastic Surgery · 113d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #7 44/47
K834189
Imm Enterprises , Ltd.
General & Plastic Surgery · 106d
Cleared Sep 09, 1982
UNIVERSAL SPECULUM HOLDER
K822370
Treace Medical, Inc.
General & Plastic Surgery · 34d
Cleared Sep 09, 1982
EAR SURGERY SPECULUM
K822373
Treace Medical, Inc.
General & Plastic Surgery · 34d
Cleared Aug 11, 1982
EAR SPECULI
K822164
Kelleher Corp.
General & Plastic Surgery · 19d
Cleared Jul 10, 1979
EAR AND NOSE SPECULA
K791123
Xomed, Inc.
General & Plastic Surgery · 25d
Cleared May 09, 1978
OTOSCOPE SPECULA
K780723
Abco Dealers, Inc.
General & Plastic Surgery · 7d
Cleared Jan 17, 1978
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
K772370
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
FARRIOR OVAL SPECULUM
K772380
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
THIN-BLADED NASAL SPECULUM
K772385
Edward Weck, Inc.
General & Plastic Surgery · 21d

About Product Code EPY - Regulatory Context