510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102898Substantially Equivalent

Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography Catheter without Cervical Cone

Panpac Medical Corporation, Shi-Chih City, Taipei Hsien, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K102898 is the FDA 510(k) clearance record for BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE, a class II device, cleared for Panpac Medical Corporation on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list 12 510(k) clearances for Panpac Medical Corporation, from to . As of , FDA records show no recalls naming K102898.

Clearance record

Decision date
Received
(441 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Panpac Medical Corporation # 202, 6f-1.2, Sec.3, Shi-Chih City, Taipei Hsien, TW
510(k) summary
Statement
Third party review
No

Clearances, product code LKF

Trailing 12 months
2 clearances under product code LKF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260