Product code FDE— Gastroenterology, Urology

“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 FDE between 1991 and 1996, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19961 clearance
• 19951 clearance
• 19941 clearance
• 19911 clearance

• Mitsubishi Cable America, Inc.1 clearance
• Candela Laser Corp.1 clearance
• Boston Scientific Corp1 clearance
• Aslan Medical Technologies, Ltd.1 clearance

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K955717 — ENDOSCOPE INTRODUCER KITMitsubishi Cable America, Inc.·1996-04-18
• K950924 — ASLAN KNOT PUSHERAslan Medical Technologies, Ltd.·1995-03-14
• K942677 — GEENEN/ZEBRA GUIDELINESBoston Scientific Corp·1994-07-21
• K912443 — CANDELA INTRODUCER SHEATH SYSTEMCandela Laser Corp.·1991-08-16