Product code KYP— General Hospital

“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.”

FDA has cleared 4 devices under product code KYP between 1983 and 1988, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19881 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance

• Saffeta, Inc.1 clearance
• Medie Group1 clearance
• Marlo Surgical Technology1 clearance
• Chiron Vision Corp.1 clearance

• K883839 — ND:YAG LASER SPECTACLES, MST MODEL #YLS-5Marlo Surgical Technology·1988-12-09
• K844048 — DR. HESSEL'S INSECT POISON REMOVERMedie Group·1985-01-23
• K842015 — SAWYER FIRST AID KITSaffeta, Inc.·1984-07-06
• K831312 — LOPEZ-HORN CARRIERChiron Vision Corp.·1983-05-25