Medical Device Manufacturer · JP , Ayabe, Kyoto

Gunze Limited - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2013

Recent clearances: NEOVEIL Staple Line Reinforcement, PELNAC Meshed Bilayer Wound Matrix, PELNAC Wound Matrix

5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Gunze Limited General & Plastic Surgery ✕

5 devices
1-5 of 5
Cleared Aug 26, 2022
NEOVEIL Staple Line Reinforcement
K221487 · OXC
General & Plastic Surgery · 95d
Cleared Jul 14, 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · KGN
General & Plastic Surgery · 255d
Cleared Feb 09, 2022
PELNAC Wound Matrix
K213573 · KGN
General & Plastic Surgery · 91d
Cleared Apr 29, 2020
PELNAC Bilayer Wound Matrix
K191992 · KGN
General & Plastic Surgery · 279d
Cleared Nov 15, 2013
NEOVEIL
K130997 · OXC
General & Plastic Surgery · 219d
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